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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO; SURGICAL MESH Back to Search Results
Catalog Number 5955790
Device Problems Migration or Expulsion of Device (1395); Defective Device (2588); Material Deformation (2976); Insufficient Information (3190)
Patient Problems Neuropathy (1983); Scarring (2061); Disability (2371)
Event Date 09/07/2016
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the bard/davol ventralight st w/echo device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges additional surgery for pain in abdomen, neuopothy, scarring and recurrent hernia.No medical records have been provided; however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2015: the patient was implanted with a bard/davol ventralight st w/echo for the repair of an incisional hernia.Ni/ni/ni: the patient started experiencing pain radiating from her abdomen and neuropathy.The patient's physicians elected for a repair surgery of the recurrent hernia.On (b)(6) 2016: the patient underwent repair surgery.Upon entering the abdominal cavity, patient's surgeon noted that the mesh had failed and repaired the recurrent hernia with a non-bard/davol mesh.The patient has suffered pain, neuropathy, scarring, and will continue to suffer physical pain and mental anguish from her hernia mesh injury.As a result of having the mesh implanted, patient has experienced significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedure.
 
Manufacturer Narrative
Currently, it is unknown to what extent the bard/davol ventralight st w/echo device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges additional surgery for pain in abdomen, neuopothy, scarring and recurrent hernia.No medical records have been provided; however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.H11: this is an addendum to the initial emdr to document information provided via patient medical records and additional outcomes alleged by the patient's attorney.The information provided indicates that the ventralight st mesh was explanted during a subsequent surgery due to a recurrent hernia.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use as a possible complication.The explant procedure medical record does not support the allegation of mesh migration or the allegation that "the mesh rolled up and attached to internal organs." the additional information obtained from the medical records provided, does not change the initial determination.No conclusion can be made.Updated fields: a2, a4, b4, b5, b7, d7, g1, g4, g7, h2, h6, h11.Note: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : not returned.
 
Event Description
The following was alleged by the patient's attorney: (b)(6) 2015: the patient was implanted with a bard/davol ventralight st w/echo for the repair of an incisional hernia.Ni/ni/ni: the patient started experiencing pain radiating from her abdomen and neuropathy.The patient's physicians elected for a repair surgery of the recurrent hernia.(b)(6) 2016: the patient underwent repair surgery.Upon entering the abdominal cavity, patient's surgeon noted that the mesh had failed and repaired the recurrent hernia with a non-bard/davol mesh.The patient has suffered pain, neuropathy, scarring, and will continue to suffer physical pain and mental anguish from her hernia mesh injury.As a result of having the mesh implanted, patient has experienced significant mental and physical pain and suffering and mental anguish, has sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedure.Addendum per medical records provided by the patient's attorney and additional allegations: per medical records: (b)(6) 2016 the patient was diagnosed with recurrent ventral hernia and underwent a ventral hernia repair with a non bard/davol mesh.Per the operative report details, "incision through the previously created laparotomy incision was dissected and immediately a large herniation was identified.The previous mesh (ventralight st) was visible.Entered abdominal activity through the mesh and removed the mesh in its entirety, taking care not to injure any of the structures beneath." per patient's attorney: alleged adhesions, recurrence, mesh migration, pain and suffering, scarring and neuropathy.As reported by the attorney, "the mesh rolled up and attached to internal organs.".
 
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Brand Name
VENTRALIGHT ST W/ECHO
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key7903918
MDR Text Key121562371
Report Number1213643-2018-03262
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031762
UDI-Public(01)00801741031762
Combination Product (y/n)N
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/28/2016
Device Catalogue Number5955790
Device Lot NumberHUYH1323
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age46 YR
Patient Weight109
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